Report raises concerns on St. Jude device testing

Article by: BARRY MEIER and KATIE THOMAS

New York Times

November 21, 2012 - 12:05 AM

A report on an inspection of a St. Jude Medical Inc. facility released Tuesday by federal officials found significant flaws in the company's testing and oversight of a heart device component, a copy of the document shows. The report may also raise questions about why St. Jude executives did not fully divulge the inspection's findings when they released a version of them to investors and others.

The report by the Food and Drug Administration centered on a product known as the Durata, a critical electrical wire that connects an implanted defibrillator to a patient's heart. St. Jude uses a material called Optim to insulate the component and preserve its electrical integrity. But questions about the durability of Optim have arisen after failure of another St. Jude lead that used an earlier material and has been recalled.

In October, St. Jude filed a version of the inspection report with the Securities and Exchange Commission but blacked out several parts that referred to the Durata. At the time, the company said it was redacting the report on its "good faith interpretation" of how the FDA would act when releasing the document in response to a Freedom of Information Act request.

The FDA, however, did not block out product names when releasing the report.

Amy Jo Meyer, a spokeswoman for Little Canada-based St. Jude, said Tuesday none of the observations in the inspection report "identified a specific issue regarding the clinical or field performance of any of our products." Beyond that, she said, St. Jude would not comment.

The company has been under fire for months for its handling of problems with an earlier lead, called the Riata, that was failing in many patients. St. Jude stopped selling that lead in 2010, but it is estimated to have been implanted in 128,000 patients worldwide.

The company has aggressively defended the safety of the Durata, made with the newer Optim coating, which St. Jude says is not prone to the same failure that plagued the Riata. But some cardiologists have said they will not use it until more is known about long-term safety.